COVID-19 Vaccinations in Pregnancy: Comparative Evaluation of Acute Side Effects and Self-Reported Impact on Quality of Life between Pregnant and Nonpregnant Women in the United States.

OBJECTIVE: The objective of this study was to describe the acute side effects experienced by pregnant women who received a coronavirus disease 2019 (COVID-19) vaccine in the United States and to compare their experience to nonpregnant women of similar age. STUDY DESIGN: Adults who received a COVID-19 vaccine in the United States were invited via social media to enroll in an online, longitudinal, community-based registry ( www.helpstopCOVID19.com ). Participants self-reported pregnancy status, vaccination dates, manufacturer, acute side effects, impact on work and self-care, medical consultation, and hospitalization. This analysis was restricted to women aged 20 to 39 at the time of vaccination. Side effects reported by pregnant women were compared to those reported by nonpregnant women. RESULTS: This analysis included 946 pregnant women, with 572 (60%) receiving at least one dose of Pfizer, 321 (34%) Moderna, and 53 (6%) J&J, and 1,178 nonpregnant women. Demographic and medical history were similar across manufacturers for both cohorts.Overall, pregnant women reported similar side effects as nonpregnant women, with the most common being injection site reactions (83 vs. 87%), fatigue (72 vs.78%), and headache (45 vs. 59%). Pregnant women reported fewer side effects (median: 3 vs. 4, respectively). In both cohorts, very few reported seeking medical care (<5%) or being hospitalized (<0.3%) after vaccination. Fewer pregnant women reported working less after vaccination than nonpregnant women (32 vs. 40%) or trouble with self-care (32 vs. 46%), respectively. CONCLUSION: Pregnant women reported similar COVID-19 vaccine side effects as nonpregnant women, although fewer total side effects; pregnant women judged these side effects to have less impact on work and self-care. While these results do not address pregnancy outcomes or long-term effects, findings about acute side effects and impact offer reassurance for all three vaccines in terms of tolerability. KEY POINTS: · COVID vaccines were well tolerated by pregnant women.. · Pregnant women reported fewer total side effects.. · Pregnant women reported less impact on work and self-care..

Evaluating real-world COVID-19 vaccine effectiveness using a test-negative case-control design.

Aim: It is important to assess if clinical trial efficacy translates into real-world effectiveness for COVID-19 vaccines. Materials & methods: We conducted a modified test-negative design (TND) to evaluate the real-world effectiveness of three COVID-19 vaccines. We defined cases in two ways: self-reported COVID-19-positive tests, and self-reported positive tests with ≥1 moderate/severe COVID-19 symptom. Results: Any vaccination was associated with a 95% reduction in subsequently reporting a positive COVID-19 test, and a 71% reduction in reporting a positive test and ≥1 moderate/severe symptom. Conclusion: We observed high effectiveness across all three marketed vaccines, both for self-reported positive COVID-19 tests and moderate/severe COVID-19 symptoms. This innovative TND approach can be implemented in future COVID-19 vaccine and treatment real-world effectiveness studies. Clinicaltrials.gov identifier: NCT04368065.

COVID-19 Vaccination Breakthrough Infections in a Real-World Setting: Using Community Reporters to Evaluate Vaccine Effectiveness.

Purpose: Coronavirus disease 2019 (COVID-19) has highlighted the need for new methods of pharmacovigilance. Here, we use adult community volunteers to obtain systematic information on vaccine effectiveness and the nature and severity of breakthrough infections. Methods: Between December 15, 2020 and September 16, 2021, 11,826 unpaid community-based volunteers reported the following information to an on-line registry: COVID-19 test results, vaccination (Pfizer, Moderna, or Johnson & Johnson) and COVID-19 symptoms. COVID-19 infections were described based on vaccination status at the time of infection: 1) fully vaccinated, 2) partially vaccinated (received first of two-dose vaccines or were <14 days post-final dose), or 3) unvaccinated. Results: Among 8554 participants who received any COVID-19 vaccine, COVID-19 infections were reported by 74 (1.0%) of those who were fully vaccinated and 198 (2.3%) of those who were partially vaccinated at the time of infection. Among the 74 participants who reported a breakthrough infection after full vaccination, the median time from vaccination to reported positive test result was 104.5 days (interquartile range: 77-135 days), with no difference among vaccine manufacturers. One quarter (25.7%) of breakthrough infections in the fully vaccinated cases were asymptomatic and most (>97%) fully vaccinated participants reported no symptoms or only mild symptoms compared to 89.3% of the unvaccinated cases. Only 1.4% of fully vaccinated participants reported experiencing at least 3 moderate-to-severe symptoms compared to 7.8% in the unvaccinated. Conclusion: Person-generated health data, also referred to as patient-reported outcomes, is a useful approach for quantifying breakthrough infections and their severity and for comparing vaccines. Trial Registration: Clinicaltrials.gov NCT04368065, EU PAS Register EUPAS36240.

How frequent are acute reactions to COVID-19 vaccination and who is at risk?

INTRODUCTION: Our objective was to describe and compare self-reported side effects ofCOVID-19 vaccinesin theUSA. METHODS: Aweb-basedregistry enrolled volunteers who received a COVID-19 vaccine between March 19-July 15, 2021. We collected self-reported short-term side effects, medical consultation, hospitalization, and quality of life impact following completed vaccination regimens (Pfizer, Moderna, J&J). RESULTS: We recruited 6,966 volunteers who completed their full course of vaccination (median age 48 years, IQR 35.0-62.0; 83.6% female): Pfizer 3,486; Moderna 2,857; J&J 623. Few (3.1%) sought medical care for post-vaccination side effects. Hospitalization (n = 17; 0.3%) and severe allergic reactions (n = 39; 0.6%) also were rare. Those with autoimmune disease or lung disease were approximately twice as likely to seek medical care (adjusted odds ratio (aOR) 2.01, 95% CI:1.39; 2.92 and aOR 1.70, 95% CI: 1.12; .58 respectively). 92.4% of participantsreported ≥ 1side effect (median 3), with injection site reactions (78.9%), fatigue (70.3%), headache (49.0%) reported most frequently. More side effects were reported after the second dose of two-dose vaccines (medians: 1 vs. 2 for Pfizer and 1 vs. 3 for Moderna for first and second doses respectively) versus 3 for J&J's single-dose vaccine. For the employed, the median number of workdays missed was one. Diabetics and those vaccinated against influenza were substantially less likely to report 3 or more symptoms (aOR 0.68, 95% CI: 0.56;0.82] and aOR 0.82, 95% CI: 0.73;0.93, respectively). DISCUSSION: The total side effect burden was, not unexpectedly, greater with two-dose regimens but all three vaccines appear relatively safe. Very few subjects reported side effects serious enough to warrant medical care or reported post-vaccination hospitalization. While these findings do not address possible long-term effects, they do inform on their short-term safety and tolerability and will hopefully provide some reassurance and positively inform the benefit-risk and pharmacoeconomic assessment for all three vaccines. See Clinicaltrials.gov NCT04368065.

Identification of a Vulnerable Group for Post-Acute Sequelae of SARS-CoV-2 (PASC): People with Autoimmune Diseases Recover More Slowly from COVID-19.

PURPOSE: Evidence is emerging that a significant percentage of COVID-19 cases experience symptom persistence beyond 30 days and go on to develop post-acute sequelae. Our objective was to compare the risk for COVID-19 symptom persistence by self-reported use of medications for autoimmune disease among participants of an on-line COVID-19 registry. PATIENTS AND METHODS: A community-based online survey collected weekly data on COVID-19 symptom presentation. Participants who completed informed consent online, reported a positive COVID-19 test result within 14 days prior to enrollment and also reported demographics, underlying illnesses, and medication use were included. Symptom presence and severity were evaluated weekly after enrollment and compared between participants reporting use of medications for autoimmune conditions and all others. Logistic regression was used to evaluate the odds of more severe acute illness and symptom persistence approximately 30 days after enrollment. RESULTS: A total of 1,518 COVID-19-positive participants were included. Participants reporting use of medications for autoimmune disease (n=70) were more likely to have experienced symptoms at all time points over a 30-day time period and were more likely to report more severe presentation of COVID-19 during acute illness (adjusted OR (95% CI)=1.32 (0.76-2.29)) compared to those reporting not taking medications for autoimmune disease. At about 30 days after enrollment, users of medications for autoimmune disease were more than twice as likely to report three or more symptoms (adjusted OR (95% CI)=2.53 (1.21-5.29)). In particular, their risk of persistent shortness of breath and fatigue was elevated (adjusted OR (95% CI)=2.66 (1.15-6.18) and 4.73 (2.17-10.34), respectively). CONCLUSION: Individuals with underlying autoimmune conditions appear to be particularly vulnerable to post-acute sequelae from COVID-19; early intervention might be considered.

Self-reported symptoms from exposure to Covid-19 provide support to clinical diagnosis, triage and prognosis: An exploratory analysis.

BACKGROUND: Symptomatic COVID-19 is prevalent in the community. We identify factors indicating COVID-19 positivity in non-hospitalized patients and prognosticators of moderate-to-severe disease. METHODS: Appeals conducted in April-June 2020 in social media, collaborating medical societies and patient advocacy groups recruited 20,476 participants ≥18 years who believed they had COVID-19 exposure. Volunteers consented on-line and reported height, weight, concomitant illnesses, medication and supplement use, residential, occupational or community COVID-19 exposure, symptoms and symptom severity on a 4-point scale. Of the 12,117 curated analytic population 2279 reported a COVID-19 viral test result: 865 positive (COVID+) and 1414 negative (COVID-). RESULTS: The triad of anosmia, ageusia and fever best distinguished COVID+ from COVID-participants (OR 6.07, 95% CI: 4.39 to 8.47). COVID + subjects with BMI≥30, concomitant respiratory disorders or an organ transplant had increased risk of moderate-to- severe dyspnoea. Race and anti-autoimmunity medication did not affect moderate-to-severe dyspnea risk. CONCLUSIONS: The triad of anosmia, ageusia and fever differentiates COVID-19. Elevated risks of severe symptoms outside the hospital were most evident among the obese and those with pulmonary comorbidity. Race and use of medication for autoimmune disease did not predict severe disease. These findings should facilitate rapid COVID-19 diagnosis and triage in settings without testing.